# US 11,298,463 B2 · Method of assembling and filling a drug delivery device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,463 B2 - Document ID: US11298463B2 - Status: Granted - Kind: B2 - Application number: 16/839,267 - Filed: 2020-04-03 - Published: 2020-07-23 - Granted: 2022-04-12 - Earliest claimed: 2011-10-14 - Assignees: Amgen Inc. - Applicants: Amgen Inc. - Inventors: Francisca Tan-Malecki; Ronald Forster; Scott M. Nunn; Mark D. Holt; Son C. Tran; Sheldon Moberg - Web page: https://patentgrep.com/patent/US11298463B2 ## CPC - A61M 5/31: Details - A61M 5/1452: {pressurised by means of pistons} - A61M 5/148: flexible (A61M5/155 takes precedence) - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61M 5/162: Needle sets, i.e. connections by puncture between reservoir and tube - A61M 5/1626: {Needle protectors therefor (in combination with syringes A61M5/3202; protectors for sharps A61B50/3001)} - A61M 5/172: electrical or electronic - A61M 5/2466: {by piercing without internal pressure increase (A61M5/2429 takes precedence)} - B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like} - B65B 7/2821: {applying plugs or threadless stoppers (for bottles or jars B67B1/04)} - B65B 55/08: by irradiation - B65B 55/10: by liquids or gases - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/2455: {with sealing means to be broken or opened} - A61M 2005/247: {with fixed or steady piercing means, e.g. piercing under movement of ampoule} - A61M 2005/2474: {with movable piercing means, e.g. ampoule remains fixed or steady} - A61M 2005/3114: {Filling or refilling} - A61M 2207/00: Methods of manufacture, assembly or production - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) ## Abstract An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state. ## Claims ### Claim 1 A method of assembling an injector, the method comprising: providing a container having a wall defining an interior surface and a seal assembly including a septum having an interior surface and an exterior surface, the wall and the interior surface of the septum defining a reservoir; providing a fluid delivery system physically separate from the container, the fluid delivery system comprising a container needle having a point; providing an injection member physically separate from the container needle and configured to be connected in fluid communication with the container needle during use of the injector; sterilizing the container including the reservoir and fluid delivery system while the container and the fluid delivery system are separate from each other; filling the sterile reservoir of the container with a volume of a drug product under sterile conditions in a first assembly space, the drug product comprising a granulocyte colony-stimulating factor (G-CSF); after sterilizing the container and filling the sterile reservoir, attaching the fluid delivery system to the container in a second assembly space such that the point of the container needle is disposed adjacent to or within the seal assembly to define a storage state, wherein the first assembly space has a higher level of freedom from contamination than the second assembly space; and attaching the container needle to an actuator, the actuator adapted to move the container needle from the storage state to a delivery state wherein the container needle is disposed through the septum, into the sterile reservoir, and in fluid communication with the drug product for delivery to a patient via the injection member, wherein the point of the container needle is configured such that, in moving from the storage state to the delivery state, the point of the container needle is disposed through the septum but does not contact any component directly contacting the exterior surface of the septum, wherein the seal assembly comprises a second wall disposed adjacent to the septum without contacting the exterior surface of the septum, and wherein the container needle is disposed through the second wall of the seal assembly at least in the delivery state. ### Claim 2 (depends on 1) The method of claim 1, further comprising packaging the injector. ### Claim 3 (depends on 1) The method of claim 1, further comprising attaching a stopper to the container after filling the reservoir, thereby sealing the filler reservoir. ### Claim 4 (depends on 1) The method of claim 1, wherein attaching the fluid delivery system to the filled container comprises attaching the container needle such that the container needle does not penetrate a wall of the seal assembly. ### Claim 5 (depends on 4) The method of claim 4, wherein attaching the stopper to the container includes attaching the stopper to the container in a space operated as an aseptic Class 100 clean room. ### Claim 6 (depends on 1) The method of claim 1, wherein sterilizing the container comprises (a) using e-beam technology, (b) treatment with chlorine dioxide, and/or (c) treatment with vapor phase hydrogen peroxide. ### Claim 7 (depends on 1) The method of claim 1, wherein filling the sterile reservoir of the container includes filling the sterile reservoir in a space operated as an aseptic Class 100 clean room. ### Claim 8 (depends on 1) The method of claim 1, prior to attaching the fluid delivery system to the container, inspecting the filled container in a space operated as an aseptic Class 10,000 clean room. ### Claim 9 (depends on 1) The method of claim 1, prior to attaching the fluid delivery system to the container, moving the filled container to an assembly space operated as an aseptic Class 10,000 clean room. ### Claim 10 (depends on 1) The method of claim 1, further comprising swabbing a surface of the seal assembly prior to attaching the fluid delivery system. ### Claim 11 (depends on 1) The method of claim 1, wherein the reservoir of the container is sterilized in a first clean room, and the fluid delivery system is sterilized in a second clean room. ### Claim 12 (depends on 1) The method of claim 1, wherein sterilizing the container comprises a radiation sterilization treatment and/or a gaseous sterilization treatment. ### Claim 13 (depends on 1) The method of claim 1, wherein the fluid delivery system comprises flexible tubing configured to provide fluid communication between the container needle and the injection member during use of the injector. ### Claim 14 (depends on 1) The method of claim 1, comprising sterilizing, while in the second assembly space, a surface of the seal assembly to be penetrated by the point of the container needle prior to attaching the fluid delivery system to the container. ### Claim 15 A method of assembling an injector, the method comprising: providing a container having a wall defining an interior surface and a seal assembly including a septum having an interior surface and an exterior surface, the wall and interior surface of the septum defining a reservoir; providing a fluid delivery system physically separate from the container, the fluid delivery system comprising a container needle having a point; providing an injection member physically separate from the container needle and configured to be connected in fluid communication with the container needle during use of the injector; sterilizing the container including the reservoir and fluid delivery system while the container and the fluid delivery system are separate from each other, wherein the container is sterilized in a first assembly space; after sterilizing the container, attaching the fluid delivery system to the container in a second assembly space such that the point of the container needle is disposed adjacent to or within the seal assembly to define a storage state, wherein the first assembly space has a higher level of freedom from contamination than the second assembly space; and attaching the container needle to an actuator, the actuator adapted to move the container needle from the storage state to a delivery state wherein the container needle is disposed through the septum, into the sterile reservoir, and in fluid communication with a drug product in the reservoir for delivery to a patient via the injection member, wherein the point of the container needle is configured such that, in moving from the storage state to the delivery state, the point of the container needle is disposed through the septum but does not contact any component directly contacting the exterior surface of the septum, wherein the seal assembly comprises a second wall disposed adjacent to the septum without contacting the exterior surface of the septum, and wherein the container needle is disposed through the second wall of the seal assembly at least in the delivery state. ### Claim 16 (depends on 15) The method of claim 15, wherein attaching the fluid delivery system to the container comprises penetrating a wall of the seal assembly with the point of the container needle to define the storage state. ### Claim 17 (depends on 16) The method of claim 16, wherein the point of the container needle is disposed within the wall of the seal assembly in the storage state. ### Claim 18 (depends on 15) The method of claim 15, wherein the fluid delivery system comprises flexible tubing configured to provide fluid communication between the container needle and the injection member during use of the injector. ### Claim 19 (depends on 15) The method of claim 15, wherein the actuator is configured to automatically move the container needle from the storage state to the delivery state. ### Claim 20 (depends on 15) The method of claim 15, wherein the actuator is configured to automatically move the container needle from the storage state to the delivery state in response to a signal received from an input device. ### Claim 21 (depends on 15) The method of claim 15, comprising sterilizing, while in the second assembly space, a surface of the seal assembly to be penetrated by the point of the container needle prior to attaching the fluid delivery system to the container. ### Claim 22 A method of assembling an injector, the method comprising: providing a container having a wall defining an interior surface and a seal assembly including a septum having an interior surface and an exterior surface, the wall and the interior surface of the septum defining a reservoir; providing a fluid delivery system physically separate from the container, the fluid delivery system comprising a container needle having a point; providing an injection member physically separate from the container needle and configured to be connected in fluid communication with the container needle during use of the injector; sterilizing the container including the reservoir and fluid delivery system while the container and the fluid delivery system are separate from each other; filling the sterile reservoir of the container with a volume of a drug product under sterile conditions in a first assembly space, the drug product comprising a granulocyte colony-stimulating factor (G-CSF); after sterilizing the container and filling the sterile reservoir, attaching the fluid delivery system to the container in a second assembly space such that the point of the container needle is disposed adjacent to or within the seal assembly to define a storage state, wherein the first assembly space has a higher level of freedom from contamination than the second assembly space; and attaching the container needle to an actuator, the actuator adapted to move the container needle from the storage state to a delivery state wherein the container needle is disposed through an uncovered portion of the exterior surface of the septum, into the sterile reservoir, and in fluid communication with the drug product for delivery to a patient via the injection member, wherein the seal assembly comprises a second wall disposed adjacent to the septum without contacting the exterior surface of the septum, and wherein the container needle is disposed through the second wall of the seal assembly at least in the delivery state. ### Claim 23 (depends on 22) The method of claim 22, wherein the second wall comprises a second septum. ### Claim 24 A method of assembling an injector, the method comprising: providing a container having a wall defining an interior surface and a seal assembly including a septum having an interior surface and an exterior surface, the wall and interior surface of the septum defining a reservoir; providing a fluid delivery system physically separate from the container, the fluid delivery system comprising a container needle having a point; providing an injection member physically separate from the container needle and configured to be connected in fluid communication with the container needle during use of the injector; sterilizing the container including the reservoir and fluid delivery system while the container and the fluid delivery system are separate from each other, wherein the container is sterilized in a first assembly space; after sterilizing the container, attaching the fluid delivery system to the container in a second assembly space such that the point of the container needle is disposed adjacent to or within the seal assembly to define a storage state, wherein the first assembly space has a higher level of freedom from contamination than the second assembly space; and attaching the container needle to an actuator, the actuator adapted to move the container needle from the storage state to a delivery state wherein the container needle is disposed through an uncovered portion of the exterior surface of the septum, into the sterile reservoir, and in fluid communication with a drug product in the reservoir for delivery to a patient via the injection member, wherein the seal assembly comprises a second wall disposed adjacent to the septum without contacting the exterior surface of the septum, and wherein the container needle is disposed through the second wall of the seal assembly at least in the delivery state. ### Claim 25 (depends on 24) The method of claim 24, wherein the second wall comprises a second septum.